SUMMARY: The chemistry technical manager’s primary functions are to oversee, develop and validate new methods for routine use, maintain instrumentation, provide technical guidance to staff and customers. Training staff on advanced instrumentation operation for the accurate method transfer to the quality control operations for a 3rd party testing lab. Duties will also include working with management in the evaluation of method development costs and on-going operational costs of running methods for routine testing where cost/benefit can be considered as methods are added to the lab.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following. Management retains the right to add to or change the duties of the position at anytime. The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.
- Provide technical advice regarding the following to include, but not limited to: audits, test results, methodologies, method development, instrumentation, and associated capabilities related to these areas.
- Advise on capabilities and assist on quoting projects using advanced equipment methods as needed for customers to submit samples for 3rd party contract chemistry testing.
- Offer a thorough equipment, reagent, supply list, etc. to include what is needed for each method development project so accurate costs can be determined for return on investment decisions.
- Review and release test results to customers to include a detailed technical explanation when applicable.
- Respond to customer requests, inquiries, and complaints and perform investigations when required.
- Design and perform special projects for internal and external customers.
- Develop, validate, and implement advanced testing methodologies for instrumentation, etc. and continuously improve methods as technology advances
- Advise and review sample submissions for business team to verify in-house method capabilities or recommend outsource testing if testing specifications are below our internal equipment limit of quantitation.
- Research compendia and be able to perform method transfers and/or method development activities following internal SOPs and comply with ISO, FDA, TGA and other regulatory requirements.
- Develop, implement and train staff with advanced laboratory instrumentation methods, operation, maintenance and calibration for equipment including HPLC, LC/MS and other chemistry instrumentation.
- Author and/or revise general methods needed for the implementation and transfer of the method to the QC department of our 3rd testing lab following the proper documentation practices required.
- Coordinate the proper maintenance, repair, calibration and operation of instrumentation following all ISO, FDA or other regulatory guidelines.
- Develop, implement and continuously improve the systems, procedures and record-keeping necessary for the organized and efficient receipt of samples for in-house chemistry testing.
- Develop, implement and control the systems, procedures and record-keeping necessary for the organized and efficient reporting, peer-review, and archiving of laboratory testing & calibration data.
- Oversee the accuracy of test records and peer-review analytical and calibration work performed as required for regulatory and ISO compliance.
- Troubleshoot anomalous results generated by the laboratory. Perform testing in support of OOS investigations.
- Maintain the safe and correct use and disposal of laboratory chemicals, solvents, etc., following all federal, state and local guidelines using GMP, GLP and other safe laboratory practices.
- Perform other roles and responsibilities per the Quality Manual and Quality Procedures.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Demonstrate expertise and proficiency with advanced analytical techniques and state-of-the-art laboratory instrumentation including HPLC, LC/MS and other laboratory equipment.
Be able to read, analyze, interpret and author testing methods and standard operating procedures.
Be able to work independently, and to interact with scientific peers in an effective manner.
Be willing to work extended hours, weekends and holidays when needed.
The position requires extensive standing. The employee is regularly required to walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds.
EDUCATION and/or EXPERIENCE: Bachelor of Science in Chemistry, Biochemistry or related field and at least five years of laboratory experience or equivalent combination of education and experience. Previous pharmaceutical, supplement or food testing experience preferred.
WORK ENVIRONMENT: Work is carried out in an analytical laboratory within a factory setting. There is considerable exposure to raw materials and chemical reagents. Personal Protective Equipment such as lab coats, gloves, safety glasses and respirators must be worn as defined by safety policy.